Trial of pIL-12 Electroporation Malignant Melanoma

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Basic Trial Information

PhaseTypeAgeTrial IDs
Phase IITreatment18 and overOMS-I100
NCI-2014-01065, 11854, NCT01502293

Trial Description

Summary

This study will assess the safety and effectiveness of intratumoral plasmid interleukin-12

DNA injection (pIL-12) with electroporation (EP) in malignant melanoma. Intratumoral pIL-12

EP is a gene therapy approach to directly induce a pro-inflammatory response within a tumor

to initiate and/or enhance anti-tumor immunity.

Further Study Information

Plasmid IL-12 (pIL-12) at a concentration of 0.5 mg/mL will be injected intratumorally at a

dose volume of ¼ of the calculated lesion volume and a dose volume per lesion of 0.1 mL for

lesions of volume < 0.4 cm3. Six pulses at field strengths of (E+) of 1500 V/cm and pulse

width of 100 μs at 1-second intervals will be administered using the OMS to each previously

injected tumor.

Two treatment regimens will be explored:

Regimen A: Treatment on Days 1, 8 and 15 every 6 weeks Regimen B: Treatment on Days 1, 5 and

8 every 6 weeks. Lesions will be treated on either Regimen A or Regimen B. Subsequent cycles

may be given at 6-week intervals, for up to 9 treatment cycles in total.

Eligibility Criteria

Inclusion Criteria:

Able to give informed consent

Adequate organ function

Female patient of childbearing potential has a negative pregnancy test within 14 days

prior to the start of study drug

Patients may have had radiation therapy, but must have progressive disease after

radiation therapy if the lesions to be treated are within the radiation field

Patients may have had prior chemotherapy or immunotherapy (vaccines, interferon,

ipilimumab, or IL-2) with progression or persistent disease

ECOG performance status 0-2

Age ≥ 18 years of age

Patients with advanced cutaneous or subcutaneous in-transit or metastatic melanoma

Exclusion Criteria:

Other clinically significant co-morbidities such as uncontrolled pulmonary disease,

uncontrolled diabetes, active CNS disease, active infection or any other condition

that could compromise the patients participation in the study according to the

investigator

History of significant cardiovascular disease (i.e. NYHA class 3 congestive heart

failure; myocardial infarction with the past 6 months; unstable angina; coronary

angioplasty with the past 6 months; uncontrolled atrial or ventricular cardiac

arrhythmias)

Life expectancy of less than 6 months

The patient is known to be positive for Human Immunodeficiency Virus (HIV) or has

another confirmed or suspected immunosuppressive or immunodeficient condition

(patients with thyroiditis are eligible)

Patients with electronic pacemakers or defibrillators are excluded from this study

Pregnant or breast-feeding women

Evidence of significant active infection (e.g., pneumonia, cellulitis, wound abscess,

etc.) at time of study enrollment

Concurrent immunotherapy, chemotherapy, or radiation therapy for duration of subject

participation on study

Prior therapy with IL-12 or prior gene therapy

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

OncoSec Medical Incorporated

    Trial Sites

    U.S.A.

    Washington
    Seattle

    Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    Shailender Bhatia
    Principal Investigator

    Link to the current ClinicalTrials.gov record.
    NLM Identifer NCT01502293

    Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.